510(k) Report

Devices descending from K960613

914 later devices reach GE Advantage Windows Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K220929ExcelsiorMerit Cro, Inc.20220—
+6K220256MIM-AblationMim Software, Inc.20224—
+6K220813Art-PlanTherapanacea20224—
+6K220684Oryx Cloud ImagingOryx Dental Software, Inc.20220—
+6K220779XDMirada Medical, Ltd.20220—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K210682SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging20211—
+6K202990NinesMeasureNines, Inc.20211—
+6K202229AI MetricsAi Metrics, LLC20200—
+6K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K193220Aview LCSCoreline Soft Co., Ltd.20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+6K190442Koios DS for BreastKoios Medical, Inc.201912—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc.20180—
+6K182815XVWeb 3DApteryx, Inc.20180—
+6K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+6K180522IGTFusionIgi Technologies20180—
+6K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+6K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+6K170540DM-DensityDensitas, Inc.20187—
+6K173636VelocityVarian Medical Systems, Inc.20188—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K173420Radiomics App v1.0Microsoft Corp.20174—
+6K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+6K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K163574Multi Modality ViewerVital Images, Inc.20171—
+6K152009DENSEEMAMMO v1.0Statlife20161—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K161130ResolutionMDCalgary Scientific, Inc.20164—
+6K160088Cydar EVCydar, Ltd.20167—
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K153014Mobius3DMobius Medical Systems, LP201613—
+6K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+6K151780CAAS WorkstationPie Medical Imaging BV20169—
+6K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.20163—
+6K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+6K143514Panther StereoSeedProwess, Inc.20150—
+6K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+6K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+6K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+6K151438Dentrix Ascend ImagingRealcloud Imaging, Inc.20150—
+6K150738VitreaViewVital Images, Inc.20158—
+6K143044CAAS A-ValvePie Medical Imaging BV20150—
+6K142850McKesson Radiology Mammography PlusMckesson Medical Imaging Company20150—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K142037QuantraHologic, Inc.20141—
+6K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+6K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+6K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+6K132684Medws Software (Variants Medview, Meddiag, Medmammo)Medecom Sarl20140—
+6K133730CO Pilot/Regius UniteaKonica Minolta, Inc.20142—
+6K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+6K13113721.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)Jvckenwood Corporation20131—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K123575MammoworkstationImage Diagnost International GmbH20132—
+6K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+6K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K121663ClarityElekta, Ltd.20121—
+6K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+6K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation20122—
+6K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd.20112—
+6K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+6K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K101796Pacsmate MMD-5201M MonitorIei Technology Corp.20100—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+6K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+6K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+6K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+6K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.20083—
+6K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+6K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+6K071331Vitrea Version 4.0Vital Images, Inc.2007821
+6K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K260500ResolutionMDResolutionMD, Inc.20260—
+7K253111Aeka ImagingGood Methods Global, Inc.20260—
+7K251484CT:VQ4Dmedical Limited20250—
+7K243884TavipilotCaranx Medical20250—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240786AutoChamberHeartLung Corporation20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+7K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+7K232514MIM – Dose AnalysisMim Software, Inc.20240—